Titel: Validation in Chemical Measurement
Herausgegeben von Paul De Bièvre, Helmut Günzler
Springer Berlin Heidelberg
8. Dezember 2004 - gebunden - 180 Seiten
Validationofmeasurementmethodshasbeenusedforavery ciated measurement uncertainty? The answer must be: no. longtimeinchemistry. Itismostlybasedontheexamination Therecanneverbeamechanismorrecipeforproducing - of a measurement procedure for its characteristics such as tomatically valid results because one can never eliminate precision, accuracy, selectivity, sensitivity, repeatability, re- theskills,theroleandtheresponsibilityoftheanalyst. producibility,detectionlimit,quanti?cationlimitandmore. ISO 9000:2000, item 3. 8. 5 de?nes validation as con?r- When focussing on quality comparability and reliability mation by examination and provision of objective evidence in chemical measurement, the ?elds of interest to this Jour- that the requirements for an intended use are ful?lled . The nal, one stumbles into various interpretations of the term revised edition of the VIM ( VIM3 ), is likely to ?ne-tune validation. It is one more example of a term which is used thisde?nitionoftheconcept validation tobe con?rmation sometimes very consistently, sometimes very loosely or in- through examination of a given item and provision of - deed ambiguously. Since the term is very common in the jective evidence that it ful?lls the requirements for a stated chemical community, it is important that its meaning be intendeduse . nd clear. Turning to the 2 edition of the International Vo- Lookingatsimplepractice, manypeoplearelookingfor cabulary of Basic and General terms in Metrology (VIM) aformaldecisionthatagivenmeasurementmethod automat- (1993), surprisingly we do not ?nd a de?nition. Webster s ically gives them valid i. e. reliable results. One wonders Dictionary of the English language (1992) tells us that val- what this has to do with stated intended use . Reliab- idation is making or being made valid . Obviously valida- ity clearly is a property of a measurement result.
P. De Bièvre: Editorial/Introduction to this volume.- F.T. Peters, H.H. Maurer: Bioanalytical method validation and its implications for forensic and clinical toxicology - A review.- I. Kuselman, B. Anisimov, A. Shenhar, A. Lepek: Validation of a computer program for atomic absorption analysis.- G.A. Ross: Instrumental validation in capillary electrophoresis and checkpoints for method validation.- L. Huber, H. Wiederoder: Qualification and validation of software and computer systems in laboratories.
Part 1.- M. Buzoianu, H.Y. Aboul-Enein: Clinical reference materials for the validation of the performance of photometric systems used for clinical analyses.- St. L.R. Ellison, A. Williams: Measurement uncertainty and its implications for collaborative study method validation and method performance parameters.- L. Huber: Qualification and validation of software and computer systems in laboratories,
Part 2.- L. Huber: Qualification and validation of software and computer systems in laboratories,
Part 3.- L. Huber: Qualification and validation of software and computer systems in laboratories,
Part 4.- S. Seno, S. Ohtake, H. Kohno: Analytical validation in practice at a quality control laboratory in the Japanese pharmaceutical industry.- R. Bettencourt, da Silva et al.: Validation of the uncertainty evaluation for the determination of metals in solid samples by atomic spectrometry.- R.J. Wells: Validation requirements for chemical methods in quantitative analysis, horses for courses?.- R.J. Wells: Validation requirements for chemical methods in quantitative analysis, horses for courses?.- Stefan, Aboul-Enein: Validation criteria for developing ion selective membrane electrode for analysis of pharmaceuticals.- S. Küppers: Is the estimation of measurement uncertainty a viable alternative to validation?.- R.C. Diaz et al.: Validation of an HPLC method for the determination of p-dichlorobenzene and naphthalene in mothrepellents.- V.J. Barwick et al.: The evaluationof measurement uncertainty from method validation studies,
Part 1.- V.J. Barwick et al: The evaluation of measurement uncertainty from method validation studies,
Part 2.- S. Linko: Automated ion selective measurement of lithium in serum. A practical approach to result-level verification in a two-way method validation.- P. Woitke et al.: Determination of Hydrocarbons in Water - Interlaboratory Method Validation prior routine monitoring.- G. Anand Kumar, G. Swarnabala et al.: Interlaboratory quality audit program for potable water - Assessment of method validation done on ICP-OES.- N. Majcen: A need for clearer terminology and guidance in the role of reference materials in method development and validation.- E. Ramoskiene et al.: Validation of salt spray corrosion test.- M. Lauwaars, E. Anklam: Method validation and reference materials.- B. Hibbert: Method validation of modern analytical techniques.- M. Holmgren: Validation of test methods - General principles and concepts.- A. Gillespie: Marketing valid analytical measurement.- R. Kadis: Analytical procedure in terms of measurement (quality) assurance.- A. Leclerq: Flexibilisation of the scope of accreditation: an important asset for food and water microbiology laboratories.- H. Hey: Legal requirements on validation of test methods for official control of foodstuffs, veterinary drug residues and element contaminants in the EC.- M. Lauwaars: Methods validation - AOAC's three validation systems.- M. Holmgren: Observing validation, uncertainty determination and traceability in developing Nordtest test methods.
From the reviews:
"The world at large has become more aware of the importance of analytical measurements and their role in defining what quality is acceptable and what is not! ... overall this is a useful compilation and would serve as a good introduction to and an overview of the field for practicing analytical chemists and scientists particularly from certified laboratories (ISO 17025 etc)." (C. Burgess, Chromatographia, Vol. 62 (3-4), 2005)
"Validation is certainly a hot topic in analytical chemistry since a couple of decades. It is not only an important topic in education of chemical students, but first of all the subject of interest for routine laboratories. ... There is no doubt, that in the field where many analytical chemist consider themselves as experts, such book brings much new and useful information ... . I am sure that this book will be appreciated by many newly educated as well as experienced analysts." (Adam Hulanicki, Chemia Analityczna, Vol. 50, 2005)